(191 days)
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No
The provided text describes a headless bone screw system for fracture fixation and does not mention any AI or ML components.
Yes
The device is a bone screw system intended for the fixation of osseous fragments or fractures, which aligns with the definition of a therapeutic device as it is used to treat or alleviate a medical condition.
No
Explanation: The device is described as a "Headless bone screw system for the fixation of osseous fragments or fractures." This indicates it is an implant used for treatment (fixation), not for diagnosis. Diagnostic devices are used to identify or characterize medical conditions.
No
The device is described as a "Headless bone screw system," which is a physical implant used for fixation of bone fragments. This clearly indicates a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided information describes a "Headless bone screw system" used for the fixation of osseous fragments or fractures. This is a surgical implant used directly within the body to stabilize bones.
- Intended Use: The intended use is for fixing bone fractures and fusions, which is a surgical procedure, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Headless bone screw system for the fixation of osseous fragments or fractures including:
HBS - MINI
Scaphoid fractures
Lunate fractures
Capitate
Trapezial fractures
Metacarpal and metatarsal fractures
Phalangeal fractures
Radial head fractures
Ulnar styloid fractures
Osteo-chrondral
Small joint fusions
Small joint fusions
HBS - STANDARD
Scaphoid fractures
Carpal fractures & non-unions
Capitellum fractures
Metacarpal fractures
Phalangeal fractures
Distal radial fractures
Radial head fractures
Ulnar styloid fractures
Small joint fusions
Humeral head fractures
Glenoid fractures
Intercarpal fusions
Interphalangeal fractures
Metatarsal osteotomies
Tarsal fusions
Malleolar fractures
Patellar fractures
Osteo-chrondral fractures
Odontoid fractures
Mandibular fractures
Product codes
HWC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the border of the circle. In the center of the seal is a stylized image of an eagle with three curved lines extending from its head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Schoening & Associates, Inc. c/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127
Re: K030302
Trade/Device Name: HBS Headless Bone Screw Regulation Number: 21CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 23, 2003 Received: July 24, 2003
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Mr. Kevin Walls, RAC
forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K. 0.3030 d
HBS Headless Bone Screw Device Name:
Indications for Use:
Headless bone screw system for the fixation of osseous fragments or fractures including:
| HBS - MINI | HBS - STANDARD |
|---|---|
| Scaphoid fractures | Scaphoid fractures |
| Lunate fractures | Carpal fractures & non-unions |
| Capitate | Capitellum fractures |
| Trapezial fractures | Metacarpal fractures |
| Metacarpal and metatarsal fractures | Phalangeal fractures |
| Phalangeal fractures | Distal radial fractures |
| Radial head fractures | Radial head fractures |
| Ulnar styloid fractures | Ulnar styloid fractures |
| Osteo-chrondral | Small joint fusions |
| Small joint fusions | Humeral head fractures |
| Small joint fusions | Glenoid fractures |
| Intercarpal fusions | |
| Interphalangeal fractures | |
| Metatarsal osteotomies | |
| Tarsal fusions | |
| Malleolar fractures | |
| Patellar fractures | |
| Osteo-chrondral fractures | |
| Odontoid fractures | |
| Mandibular fractures |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative And Neurological Devices 510(k) Number
Prescription Use X (Per 21 CFR 801.109)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030302